Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to announce positive data from its pharmacokinetic (“PK”) study FM58 of MED2002, the Company’s topical gel for erectile dysfunction (“ED”). MED2002 contains glyceryl trinitrate (“GTN”) as its active ingredient.
The PK study, which commenced in November 2017, evaluated the doses of 0.2%, 0.4%, 0.6% and 0.8% GTN to assess their suitability for maximising efficacy in the treatment of ED ahead of the two Phase III studies being planned by the Company for MED2002.
The highly encouraging results confirm that increasing the GTN dose beyond 0.2%, which was used in the successful Phase IIa study which reported top-line findings in September 2016, will result in broadly dose-related higher concentrations of GTN in the bloodstream. This supports the Company’s strong belief that the higher dose forms of MED 2002 should improve efficacy, particularly in the more severe cases of ED.
Strongly positive results were also seen in the other key objectives of the study. GTN demonstrated a rapid rate of absorption and was first detected in blood plasma in 4-5 minutes, reaching peak levels in the bloodstream within 10-12 minutes for all doses. These findings are important firstly as they underline the effectiveness of the DermaSys® transdermal technology, and also as they are consistent with a product that has shown a rapid onset of action in the Phase IIa study. This is a key differentiator to other ED products on the market as, when compared with PDE5 inhibitors such as Viagra® and Cialis® which are taken orally and do not take effect for at least 30 minutes and typically one hour or more1, MED2002 would allow far greater spontaneity between application and sexual intercourse.
In addition the study also measured the amount of GTN remaining after 5 minutes of the highest dose being applied to the penis. The study saw a rapid rate of absorption through the penis leaving a low GTN residue on the penis at 5 minutes. By applying a 0.8% dose, the study provides reassurance that there is likely to be minimal risk in transference of GTN to the sexual partner during intercourse, even at the higher doses. This finding also supports the side effect profile seen in the Phase IIa study where only four, mild side effects were seen in sexual partners out of 1,003 sexual intercourse attempts.
The PK study also demonstrated that the doses of GTN were well tolerated by the subjects. Adverse events reported were generally mild and at an acceptable level, even at the highest dose. Importantly, the incidence of headache, a known adverse event of GTN, did not increase significantly at the higher doses. This data compares favourably with the 0.2% dose where mild headaches reported previously had shown to occur in patients in less than 2% of intercourse attempts in the Phase IIa study.
Futura is pleased to confirm that it has demonstrated that the blood plasma concentrations of GTN of 0.2%, 0.4% and 0.6% fall within the plasma concentrations of the chosen US reference product, Nitrostat®, which is used to treat angina. The total amount of GTN appearing in the bloodstream was lower than Nitrostat® for 0.2%, 0.4% and broadly equivalent at 0.6%.
The Board is reviewing the implications of the detailed study data with regard to the planning of the Phase III studies for MED2002. Futura expects to make a further announcement on this shortly.
James Barder, Chief Executive of Futura Medical, said: “We are delighted to report the excellent data from our latest PK study for MED2002. The results show the effectiveness of our DermaSys® transdermal technology and demonstrate the potential of MED2002 as a rapid and safe treatment option for erectile dysfunction. We look forward to taking these excellent, supportive results into our future clinical programme.”
1. US patient information for Viagra® and Cialis®